Slim Sheath 22F Holmium Laser Enucleation of the Prostate (HoLEP) vs 26 F Sheath HoLEP for BPH: RCT
Benign Prostatic HyperplasiaHolmium laser enucleation of the prostate (HoLEP) is routinely performed with 24F, 26F, and 28F laser scopes. Proponents of larger caliber scopes suggest that the larger scope size allows for improved visualization, hemostasis, and operative efficiencies. Proponents of a smaller scope diameter suggest that by eliminating the need for pre-HoLEP urethral dilation to accommodate a larger scope. It has also been proposed that a smaller caliber scope is less traumatic to the urethra resulting in lower rates of bladder neck contracture and urethral stricture disease. Currently, to our knowledge, there are no level one evaluation examining scope size 22F versus 26F sheath in laser enucleation outcomes. The aim of our study is to determine if a smaller diameter scope is associated with improved laser enucleation time, post-operative recovery, rates of same-day discharge, or increasing intra-operative or postoperative complication rates
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Participation Requirements
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Sex:
MALE -
Eligible Ages:
50 and up
Participation Criteria
Inclusion Criteria:
1. Males over 50 years of age at the time of enrollment
2. Referred to urology for refractory LUTS secondary to BPH
3. Failed medical (non-surgical) treatment
4. Prostate size on preoperative TRUS of \> 80 ml
5. IPSS \>15, QOL score ≥3 and Qmax \<15 ml/sec
6. Written informed consent to participate in the study
7. Ability to comply with the requirements of the study procedures
Exclusion Criteria:
1. Previous surgical treatment for BPH
2. History of prostate cancer
3. Prostate size \< 80 mL
4. History of urethral stenosis or its management
5. Known or suspected neurogenic bladder
6. Participants with active urinary tract infection until appropriately treated
7. Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study
Study Location
Thunder Bay Regional Health Sciences Centre
Thunder Bay Regional Health Sciences CentreThunder Bay, Ontario
Canada
Contact Study Team
- Study Sponsored By
- Thunder Bay Regional Health Research Institute
- Participants Required
- More Information
- Study ID:
NCT06546865